The first five CIOMS initiatives focused primarily on post-marketing safety surveillance. In contrast, the sixth CIOMS working group is currently addressing the collection, monitoring, assessment and reporting of safety data during clinical trials. Their recommendations on such issues as blinding versus unblinding and communications with investigators, ethics committees, and data/safety management boards are awaited with interest. Progress on this topic can be monitored on the new CIOMS web site (www.cioms.ch).
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